The U.S. Food and Drug Administration (FDA) has warned drug compounders of potential particulate matter in an active pharmaceutical ingredient (API) manufactured by Chinese company Taizhou Xinyou Pharmaceutical & Chemical.
The FDA MedWatch safety alert said that certain lots of baclofen may be at risk for contamination with particulates and should not be used to manufacture or compound sterile injectable drugs.
Baclofen is used to help relax certain muscles in the body. The drug acts on the spinal cord nerves, decreasing the number and severity of muscle spasms caused by multiple sclerosis or spinal cord diseases. It also relieves pain and improves muscle movement.
Taizhou manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the United States.
However, after the FDA contacted Taizhou through its U.S. agent the company confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs.
Patients who are injected with drugs made from the affected baclofen may face serious safety risks, especially if an injection is administered directly into the spinal column, the FDA warned. There is also a potential risk that some lots of the API may be contaminated by endotoxin or microorganisms.
The agency’s investigation into the matter is ongoing.
Healthcare professionals and patients should report adverse events or side effects related to the use of affected products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
